Last updated on November 2017

A phase III, multicenter, randomized, double-blind, placebocontrolled study to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer


Brief description of study

A phase III, multicenter, randomized, double-blind, placebocontrolled study to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer

Detailed Study Description

The study will include men and pre- and postmenopausal women with HR-positive, HER2- negative high risk EBC after adequate surgical resection, radiotherapy (if indicated), adjuvant or neo-adjuvant chemotherapy, and who are deemed to be eligible for adjuvant ET for at least 60 months of duration.

Clinical Study Identifier: TX133393

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Recruitment Status: Closed


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